Patients, Locally advanced and metastatic solid tumors, including head and neck squamous cell carcinoma, rectal adenocarcinoma, non-squamous non-small cell lung cancer, and colorectal adenocarcinoma. Patients, Locally advanced and metastatic solid tumors, including head and neck squamous cell carcinoma, rectal adenocarcinoma, non-squamous non-small cell lung cancer, and colorectal adenocarcinoma.
Conditions
Interventions
Cohort A1 Patients with stage III to IVB locally advanced head and neck squamous cell carcinoma LAHNSCC receiving curative intent,Cohort A2 Patients with locally advanced cT3 T4 and or N plus rectal a
Diagnostic,Diagnostic,Diagnostic
Cohort A1,Cohort A2,Cohort B
Sponsors
AVITIA Inc. 200 6666 Rue Saint-Urbain Montreal, Quebec H2S 3H1 Canada
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria A1 1.Age 18 years or older 2.Histologically confirmed LA-HNSCC Stage III to IVB 3.ECOG performance status 0 to 2 4.Undergoing one of the following NCCN, ESMO, or panPacific ESMO guidelines treatments 4.1 Definitive chemoradiotherapy CCRT 4.2 Surgery followed by post operative RT or chemoradiation 4.3 Induction with cisplatin containing regimens 1 to 3 cycles is allowed 5.Cisplatin eligible as per NCCN, ESMO, or panPacific ESMO Guidelines 5.1 Age more than 70 years OR comprehensive geriatric assessment supports cisplatin use 5.2 Adequate renal function CrCl more than 60 mL per min 5.3 Adequate hearing no grade greater than or equal to 2 ototoxicity 5.4 No preexisting grade grade greater than or equal to 2 peripheral neuropathy 5.4 ECOG 0 to 1 or highly selected ECOG 2 Inclusion Criteria A2 1.Age 18 years or older 2.Histologically confirmed rectal adenocarcinoma 3.Clinical stage cT3 to T4 and,or Nplus by imaging MRI or CT, without distant metastases 4.ECOG performance status 0 to 2 5.Adequate hematologic, hepatic, and renal function 6.Willing and able to provide signed informed consent 7.Planned to receive total neoadjuvant therapy TNT, comprising both systemic chemotherapy and long course chemoradiotherapy LCCRT, followed by curative intent total mesorectal excision TME Inclusion Criteria B 1.Age 18 years or older 2.Histologically or cytologically confirmed advanced or metastatic solid tumor from the following eligible categories 2.1 Non squamous non small cell lung cancer 2.2 Colorectal adenocarcinoma 3.ECOG performance status 0 to 2 4.Clinical indication for NGS when tissue is unavailable, insufficient, or a delay in biopsy is expected 5.Life expectancy more than 3 months 6.Written informed consent
Exclusion criteria
Exclusion criteria: Exclusion Criteria A1 1.Distant metastases at diagnosis 2.Prior malignancy within 5 years, except non melanoma skin cancer 3.Pregnant or breastfeeding 4.Known immunosuppressive conditions or autoimmune disease requiring systemic therapy 5.Participation in another interventional clinical trial that would interfere with this study protocol 6.Inability to comply with study procedures or follow-up Exclusion Criteria A2 1.Distant metastatic disease M1 2.Prior chemotherapy or pelvic radiation for rectal cancer 3.Histological subtypes other than adenocarcinoma 4.Unfit for surgery or chemotherapy due to comorbidities 5.Inability to complete TNT or undergo surgery 6.Pregnant or breastfeeding 7.Known immunosuppressive conditions or autoimmune disease requiring systemic therapy 8.Participation in another interventional clinical trial that would interfere with this study protocol 9.Inability to comply with study procedures or follow up Exclusion Criteria B 1.Participation in another interventional trial impacting molecular profiling 2.More than 2 prior lines of systemic therapy 3.Pregnancy or breastfeeding 4.Hematologic malignancy 5.Organ transplantation or active immunodeficiency 6.Investigator-judged inability to comply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort A1, A2: 1-year recurrence-free survival stratified by post-treatment ctDNA status (positive vs. negative)., For Cohort A1 A2 is At 12 months after completion of treatment. Cohort A1 A2 Assessment of 1 year RFS using clinical follow up imaging and ctDNA assay results Cohort,Cohort B: Proportion of patients whose treatment plan changed based on ctDNA results Cohort B is At the time of clinical decision making following receipt of ctDNA results Cohort B Review of records to identify treatment plan changes based on ctDNA assay results | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort A Overall survival at 1 year At twelve months after treatment Clinical follow up and records of survival status,Cohort A Interval from ctDNA detection to radiologic recurrence From first ctDNA positivity to confirmed recurrence Review of ctDNA assay date and imaging confirmed recurrence date,Cohort A ctDNA clearance patterns and survival outcomes Baseline, post-treatment and twelve months Serial ctDNA assay results at baseline posttreatment and twelve months,Cohort A and B Concordance between ctDNA and radiologic or pathologic response At each response assessment visit Comparison of ctDNA assay results with imaging or pathology findings,Cohort B Time to treatment start and ctDNA test performance measures From sample collection to treatment start Review of sample collection date reporting time assay success and mutation detection,Cohort B Effect of ctDNA results on time to treatment start After receipt of ctDNA results Review of ctDNA report date and treatment initiation date | — |
Countries
Thailand
Contacts
Public ContactAlan Patiluntakankul
Phrapokklao hospital
Outcome results
None listed